Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Primary Purpose
Encephalitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Live attenuated chimeric Japanese Encephalitis vaccine
Inactivated Hepatitis A vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Encephalitis focused on measuring Live attenuated Japanese Encephalitis vaccine, IMOJEV, CD.JEVAX, Booster, Thai children, Immunogenicity, Safety, Interchangeability, Hepatitis A vaccine, Vaccination or Other Immunization Procedure
Eligibility Criteria
Inclusion Criteria:
- Children aged 1 to <5 years on the day of inclusion
- History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
- In good general health at the time of inclusion
- Provision of informed consent by the parent(s) or legal guardian(s)
Exclusion Criteria:
- Receipt of blood or blood products in the past 3 months
- Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
- Previous receipt of 2 doses of any vaccine against JE virus
- Known hypersensitivity to any of the vaccine components
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imojev
Arm Description
Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Outcomes
Primary Outcome Measures
Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).
Secondary Outcome Measures
Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™
Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.
Full Information
NCT ID
NCT02526550
First Posted
August 9, 2015
Last Updated
October 13, 2016
Sponsor
Siriraj Hospital
Collaborators
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT02526550
Brief Title
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Official Title
Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine (IMOJEV) as a Booster Dose After a Primary Vaccination With CD.JEVAX in Thai Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital
Collaborators
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.
Detailed Description
The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis
Keywords
Live attenuated Japanese Encephalitis vaccine, IMOJEV, CD.JEVAX, Booster, Thai children, Immunogenicity, Safety, Interchangeability, Hepatitis A vaccine, Vaccination or Other Immunization Procedure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imojev
Arm Type
Experimental
Arm Description
Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Intervention Type
Biological
Intervention Name(s)
Live attenuated chimeric Japanese Encephalitis vaccine
Other Intervention Name(s)
Imojev
Intervention Description
0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
Intervention Type
Biological
Intervention Name(s)
Inactivated Hepatitis A vaccine
Other Intervention Name(s)
Havrix
Intervention Description
0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Primary Outcome Measure Information:
Title
Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Description
Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).
Time Frame
Day 0 (Baseline) and Day 28 (post-vaccination)
Secondary Outcome Measure Information:
Title
Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination
Description
Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
Time Frame
Day 0 (Baseline) and Day 28 (post-vaccination)
Title
Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™
Description
Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.
Time Frame
Up to 28 days post booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged 1 to <5 years on the day of inclusion
History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
In good general health at the time of inclusion
Provision of informed consent by the parent(s) or legal guardian(s)
Exclusion Criteria:
Receipt of blood or blood products in the past 3 months
Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
Previous receipt of 2 doses of any vaccine against JE virus
Known hypersensitivity to any of the vaccine components
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kulkanya Chokephaibulkit, Professor
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The submission of study review and results to a peer-review journal is ongoing.
Citations:
PubMed Identifier
27846060
Citation
Sricharoenchai S, Lapphra K, Chuenkitmongkol S, Phongsamart W, Bouckenooghe A, Wittawatmongkol O, Rungmaitree S, Chokephaibulkit K. Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine as a Booster Dose After Primary Vaccination With Live Attenuated SA14-14-2 Vaccine: A Phase IV Study in Thai Children. Pediatr Infect Dis J. 2017 Feb;36(2):e45-e47. doi: 10.1097/INF.0000000000001395.
Results Reference
derived
Learn more about this trial
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
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